Association Between Self-reported Web-based SCCAI and Health-related Quality of Life Index in UC Patients

NCT ID: NCT04197973

Last Updated: 2020-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2020-12-30

Brief Summary

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An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. A recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients. It is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician. The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.

Detailed Description

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An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Several indices have been used to assess disease activity in patients with UC. Mayo score is the most widely used index for UC activity measurement. Meanwhile, recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. SCCAI is consisted of only clinical items and includes items such as nocturnal diarrhea and urgent defecation which are more closely related to the quality of life of patients. In this regard, a recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients.

Since SCCAI is composed of only clinical parameters, it can be evaluated by the patients themselves. According to recent research, the self-administered SCCAI was reported to have a high correlation with the SCCAI assessed by physician (correlation coefficient = 0.79). Moreover, it is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician (Spearman's correlation = 0.79). These results suggest that the patient's self-reported SCCAI can be applied to actual clinical practice, and it will enable remote monitoring and flexible follow-up depending on the patient's disease activity. If self-administered SCCAI is to be applied as a more valid disease activity assessment tools, it also properly reflects patient's quality of life status. However, it is not yet known whether the self-administered SCCAI using web-based tools reflects the quality of life of patients.

The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.

Conditions

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Quality of Life Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of UC for \>3 months
* familiarity with online communication (e.g., use of the Internet)
* Consent for study participation

Exclusion Criteria

* Previous colon resection or other UC related bowel surgery
* Psychiatric or intellectual disability
* Lack of ability for access or use online tools
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role collaborator

Jeju National University Hospital

OTHER

Sponsor Role collaborator

Soonchunhyang University Hospital

OTHER

Sponsor Role collaborator

YooJin Lee

OTHER

Sponsor Role lead

Responsible Party

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YooJin Lee

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yoo Jin Lee, Professor

Role: STUDY_DIRECTOR

Keimyung University Dongsan Medical Center

Locations

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KeimyungUniversity

Daegu, Dalseo-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yoo Jin Lee, Professor

Role: CONTACT

82-53-258-4341

Facility Contacts

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Yoo Jin Lee

Role: primary

+82-258-4739

Other Identifiers

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2018-05-056

Identifier Type: -

Identifier Source: org_study_id

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